Regulations in Asia from China to Japan, Korea, ASEAN

Transcription

1 Regulations in Asia from China to Japan, Korea, ASEAN 1 Alain Khaiat, Ph. D. President Seers Consulting Lifetime Achievement Award in-cosmetics, Paris 2010

2 2 ASEAN The ASEAN Cosmetic Directive (ACD) is in force in all 10 ASEAN member countries; The ACD is modeled after the EU Directive (6 th amendment); Definition is same as EU, only one category of products; Ingredients are regulated by the annexes: Annex II: banned ingredients; Annex III: restricted ingredients; Annex IV: positive list of colors; Annex VI: positive list of preservatives; Annex VII: positive list of UV filters;

3 3 Company s responsibilities The company or person responsible for placing the cosmetic products in the market shall: ensure that the product will not cause damage to human health when applied under normal or reasonably foreseeable conditions of use (safety assessment); notify the regulatory authority before the product is placed on the market; keep the product s technical and safety information readily accessible to the regulatory authority (PIF: Product Information File, article 8); GMP is a mandatory requirement for the manufacturing as well as the distributing (GDP) facilities; Companies must have adequate knowledge/experience of the requirements of the Directive

4 Where are we? All countries except Thailand have transposed the ACD into local regulations; All countries are implementing the principles of ACD: Product notification; PIF requirement; Annexes to control ingredients; GMP GDP requirements; Post market surveillance; 4

5 But Indonesia: Notification with quantitative formula; Mandatory expiry date; Name of licensor if product made under license; Name of primary manufacturer if product final pack is made by a different company; Certificate of Free Sale; Letter of representation legalized; 5

6 But Thailand: Has not transposed the ACD into local regulation; Notification number to be printed; Product picture and artwork need to be uploaded for some products; 6

7 But Vietnam: Certificate of Free Sale; Letter of representation legalized; 7

8 8 Institutions ACC: ASEAN Cosmetic Committee tasked with coordination, review and monitoring of the implementation of the Directive. Composed by representatives of each Member State, ASEAN Secretariat and ASEAN Cosmetic Association (ACA); ACSB: ASEAN Cosmetic Scientific Body tasked with making recommendations to ACC on safety, technical and scientific matters (e.g. modification of annexes II to VII, borderline products);

9 9 China China regulation defines two categories: Normal cosmetics ; Special cosmetics ; 9 categories of special cosmetic based on the claim and formula: 1.Sunscreen 2.Spot corrector/anti-pigmentation/ Whitening (claim related with anti-pigmentation, spot, melanin, etc) 3.Slimming, 4.Breast care 5.Hair growth 6.Hair colors 7.Perms 8.Deodorant 9.Depilatories

10 10 China Additionally the requirements are slightly different for imported products vs. locally made products: Locally made normal cosmetics : file to be submitted to Provincial bureau, manufacturing can start before license approval; Imported products as well as locally made special cosmetics : a full dossier has to be submitted to CFDA for review by the technical review expert committee. Samples have to be submitted as well: CFDA will have them tested for hygienicchemical properties (i.e. Pb, As, Hg, methanol), toxicology (on animals) and sometimes efficacy (Sunscreen);

11 China: SFDA Tests for Registration Local Testing are mandatory for product registration: Hygienic chemical tests i.e. Mercury, Lead, Methanol, ph, etc. Microbiological tests i.e. bacterial count, fecal coliforms, etc. Toxicological tests i.e. eye irritation, skin irritation on rabbits, etc. Selective Testing based on claims and formula: Human patch test; SPF/PA test; Human use test for safety; Impurity test i.e. asbestos in talc; Ingredients tests for sunscreen, anti-spot, anti-acne claim products;

12 12 China Registration lead time is about 3 months for locally made normal cosmetics (2 months for testing + 5 days for notification) up to 12 months for imported special cosmetics ;

13 13 China CFDA has issued the list of ingredients that can be used in cosmetics: 8,783 ingredients are on the list vs. over 20,000 in INCI! If your product formula uses only ingredients from the list, you can submit it for registration; If you want to use an ingredient which is not on the list, you first have to register the ingredient; In the last 4 years only 3 ingredients have been approved! China positive list is a major blockage to innovation and consumers travel to other countries, to buy the latest product they want!

14 14 Hong Kong Definitely the easiest! There is no regulation on cosmetics; Customs requires the products to meet the regulations in one of the developed countries e.g. EU, USA, China;

15 15 India All products are in one category; list of banned, restricted ingredients, positive list of preservatives, colors and UV filters; All products must be registered at the local FDA where the product is manufactured or where the product is imported; Requirements and lead time may vary depending on the State;

16 16 India Products have to meet both the cosmetic regulations and the Bureau of Indian Standards (BIS); Standards are often outdated, takes time to change; No coordination: sometimes regulation and standard are requiring opposite things

17 17 India: animal testing regulation Rule 145-C states bluntly no person shall use any animal for cosmetic testing ; Draft rule 135-B reinforces: no cosmetic tested on animal shall be imported ; Both rules do not give information on ingredients (included or not); no information on the date of application of the ban; no grace period; etc.

18 18 India Registration Requirements: Locally made products 1. Collate all documents from respective departments; 2. Preparation and submission of dossiers; 3. Defending queries if any and follow up; 4. Obtain license to manufacture; Total 3-6 months

19 19 India Registration Requirements: Export registration 1. Collation of data; 2. Obtain the CFS; 3. Submission to the country of destination; 4. Obtaining import license; 5. Preparing for export; Total 3-6 months

20 20 India Registration Requirements: Imported products 1. Obtain required documents e.g. LOA, COA, FSC, etc. 2. Preparation and submission of dossier; 3. Defending queries if any and follow up; 4. Obtaining registration certificate (RC) number; 5. Prepare for importation; Total: 6-9 months

21 21 India GSR 137 related to metrology of packaged goods requires cosmetics to bear on the top of the main display panel a: Red or brown dot for non-vegetarian products; Green dot for vegetarian products; The rule was published on 17 June 2014, with a date of application of 1 st July 2014! There is no definition of vegetarian cosmetics, there is no grace period. The industry associations are fighting the rule;

22 22 Japan No change in the regulation; Two categories: Cosmetics Quasi Drug Cosmetics: simple: all ingredients allowed except those on the negative list, positive list for preservatives, organic UV filters, Tar colors. Notification of foreign manufacturer (1 day), notification of product (1 day), notification of importation (2 weeks);

23 23 Japan: Quasi Drug Whitening, acne, dandruff, skin chapping, sterilizing the skin, medicated product ; Active ingredients must be in the positive list; Non active ingredients must be in the positive list; Registration: foreign manufacturer (4-6 months); Product registration (6 months or more); Importation license (2 weeks); New ingredients: tests to be done take up to 3 years and cost is ~3MMUS$;

24 24 Japan: Quasi Drug The recent problem on a whitening product using a newly approved ingredient highlights, yet again, that regulating products as Quasi-Drug or long approval processes for registrations are not a guaranty for safety;

25 25 Korea 3 categories: Cosmetics, Functional Cosmetics, Quasi-Drugs; Cosmetics: no registration required, but need FSC, notarized formula and BSE certificate to import products. Lists of banned ingredients, positive lists for preservatives, colors, UV filters; Functional Cosmetics: Whitening, Sunscreen, anti-wrinkles. Positive list of active ingredients. Registration takes about 6 months; Quasi-Drug: acne, mouthwash, hair dyes, etc. registration takes about 10 months;

26 26 Taiwan 2 categories: cosmetics or medicated cosmetics. Negative list, positive list for sunscreens, preservatives, colors, hair dyes, whitening actives, antibacterial, antiperspirant; Cosmetics: notification; Medicated cosmetics: e.g. acne, whitening, sunscreen: registration (~ 4/6 months);

27 27 THANK YOU